Esophageal Cooling During Ablation for Atrial Fibrillation
(eCool-US Trial)
Trial Summary
What is the purpose of this trial?
Atrial fibrillation (AF) is a common debilitating heart rhythm condition that can cause heart failure and negatively impact a patient's outlook in terms of symptoms and disability. It is an irregular fast heart rhythm disorder coming from the top chamber of the heart (left atrium). Catheter ablation treatment has been shown to be effective in controlling or eliminating AF and its associated symptoms. This is now a common and effective treatment option for patients suffering with AF. During ablation, thermal energy is applied in the top chamber of the heart (the left atrium) to abolish abnormal electrical signals that cause AF. It is generally a safe procedure, but one potential risk associated with this procedure is damage to the esophagus caused by thermal energy being transmitted to the esophagus from the heart. The esophagus sits just behind the heart chamber where ablation work is performed, about 5mm away, so it is vulnerable to damage. Although the risk of severe esophageal damage is low, if it occurs it can be serious as the patient may become very ill as a result. In recent studies, it was shown that a more advanced type of esophageal probe (ensoETM) that cools the esophagus during ablation is better at protecting the esophagus from ablation-related injury compared to the standard care temperature monitoring probe currently used. The ensoETM is a CE marked and FDA-cleared device, with an intended purpose of controlling patient temperature and has received marketing authorization from FDA to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures. The purpose of this study is to determine if the long-term efficacy outcome results obtained in single pilot studies can be replicated in a prospective, multi-center randomized controlled trail comparing the the esophageal cooling probe versus a standard of care esophageal temperature monitoring probe. There is a 50:50 chance of the esophageal cooling probe being used during AF ablation for participants.
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. It's best to consult with the trial coordinators or your doctor for guidance.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the idea that Esophageal Cooling During Ablation for Atrial Fibrillation is an effective treatment?
The available research shows that using the ensoETM, an esophageal cooling device, can reduce thermal injury to the esophagus during radiofrequency ablation for atrial fibrillation. This is important because such injuries can lead to serious complications. However, some studies indicate that esophageal temperature monitoring alone does not significantly reduce the risk of esophageal injury compared to not using it. More research is needed to fully understand the effectiveness of esophageal cooling during this treatment.12345
What data supports the effectiveness of the treatment ensoETM for esophageal cooling during atrial fibrillation ablation?
What safety data exists for esophageal cooling during AF ablation?
The safety data for esophageal cooling during atrial fibrillation (AF) ablation is mixed. Studies have evaluated different temperature monitoring probes and their impact on esophageal injury. A meta-analysis found no significant difference in esophageal injury rates between groups with and without luminal esophageal temperature (LET) monitoring, indicating that the role of temperature monitoring in reducing esophageal thermal lesions is not yet established. Some studies suggest that multi-sensor probes may increase the detection of intraluminal temperature and risk of esophageal injury compared to single-sensor probes. Overall, more randomized controlled trials are needed to assess the true impact of esophageal cooling and temperature monitoring on safety during AF ablation.12456
Is esophageal cooling during atrial fibrillation ablation safe for humans?
Esophageal cooling during atrial fibrillation ablation has been studied to see if it can reduce the risk of esophageal injury, which is a potential complication of the procedure. Some studies suggest that monitoring esophageal temperature might help, but the results are not conclusive, and more research is needed to confirm its safety and effectiveness.12456
Is esophageal cooling a promising treatment during atrial fibrillation ablation?
How is esophageal cooling during ablation for atrial fibrillation different from other treatments?
Esophageal cooling with the ensoETM device is unique because it actively cools the esophagus during atrial fibrillation ablation, reducing the risk of thermal injury, which can lead to serious complications like atrioesophageal fistula. This approach is different from standard temperature monitoring, which only observes temperature changes without actively preventing them.12356
Research Team
David Callans, MD
Principal Investigator
University of Pennsylvania
Eligibility Criteria
This trial is for AF patients suitable for ablation treatment under general anesthesia, as per guidelines. They must have already decided on this procedure and be waiting for it. It's not open to those who can't consent, can't follow up with endoscopy, are younger than 18 or older than 85, or have a history of upper GI tract bleeding or esophageal conditions that contraindicate instrumentation during ablation.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo AF ablation with either the esophageal cooling probe or standard temperature monitoring probe under general anesthesia
Follow-up
Participants may have an optional endoscopy camera between 12-72 hours post-ablation to assess esophageal thermal damage
Long-term Follow-up
Participants are monitored for freedom from atrial arrhythmia and incidence of major adverse events at 3, 6, and 12 months post-ablation
Treatment Details
Interventions
- ensoETM. Esophageal cooling during AF ablation
- Esophageal temperature monitoring probe
ensoETM. Esophageal cooling during AF ablation is already approved in European Union, United States for the following indications:
- Esophageal protection during atrial fibrillation ablation
- Reducing the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures
Find a Clinic Near You
Who Is Running the Clinical Trial?
Advanced Cooling Therapy, Inc., d/b/a Attune Medical
Lead Sponsor
Kansas City Cardiac Arrhythmia Research LLC
Collaborator
Attune Medical
Collaborator
The Queen Elizabeth Hospital
Collaborator
Berry Consultants
Collaborator
Guy's and St Thomas' NHS Foundation Trust
Collaborator
Royal Brompton & Harefield NHS Foundation Trust
Collaborator
University of Colorado, Denver
Collaborator
Texas Cardiac Arrhythmia Research Foundation
Collaborator
Beth Israel Deaconess Medical Center
Collaborator